NCT03679286

Comparative Analysis of PCM With ROTEM in the Measurement of Viscoelastic Coagulation Parameters

Comparative Analysis of the Entegrion Point of Care Coagulation Monitor (PCM) With ROTEM in the Measurement of Viscoelastic Coagulation Parameters

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Entegrion, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine if PMC viscoelastic coagulation parameters correlate with those generated by a marketed device in adult patients who require hemostasis monitoring or who are at risk of bleeding or thrombotic indications

Detailed description

The primary aim of this study is a performance evaluation of the PCM coagulation monitor in comparison to the ROTEM thromboelastometry system. To include a measurement of the entire range of the test system, subjects with a medical management need that requires the measurement of their hemostasis status (such as PT/PTT, INR) or are at risk for being hypo-coagulable or hyper-coagulable will be included in this study.

Conditions

• Hemostasis Monitoring

Interventions

Type	Name	Description
DEVICE	PCM and ROTEM	Test of blood sample by both PCM and ROTEM

Timeline

• Start date: 2018-08-20
• Primary completion: 2020-12-31
• Completion: 2021-03-31
• First posted: 2018-09-20
• Last updated: 2020-04-16

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study